Funding Opportunity Title

Activity Code

Announcement Type

New

Related Notices

December 05, 2014 - See Notice NOT-ES-15-006. Technical Assistance Webinar for ES-14-012 "Environmental Influences during Windows of Susceptibility in Breast Cancer Risk (U01)" and ES-14-011 "Coordinating Center for the Breast Cancer and the Environment Research Program (U01)"

Number of Applications

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.113, 93.393, 93.396, 93.399

Funding Opportunity Purpose

The overarching goal of the Breast Cancer and the Environment Research Program (BCERP) is to support integrated scientific research to enhance our understanding of environmental and genetic factors underlying breast cancer risk. This funding opportunity will support a Coordinating Center, which together with a group of individual transdisciplinary projects investigating the influence of environmental exposures during specific time windows on breast cancer risk, will form the BCERP Consortium. The BCERP Coordinating Center will provide intellectual leadership as well as logistic support for the BCERP Consortium. A primary role of the BCERP Coordinating Center will be to identify opportunities for cross-BCERP collaborations and extend the transdisciplinary activities of the BCERP Consortium. The Coordinating Center will also assist in disseminating BCERP research findings and facilitating an internal evaluation of the Consortium.

Key Dates

Posted Date

November 3, 2014

Open Date (Earliest Submission Date)

December 28, 2014

Letter of Intent Due Date(s)

December 28, 2014

Application Due Date(s)

January 28, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2015

Advisory Council Review

August 2015

Earliest Start Date

September 1, 2015

Expiration Date

January 29, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) solicits applications for the BCERP Coordinating Center, a unit of the Breast Cancer and Environment Research Program (BCERP). The overall objective of BCERP is to enhance our knowledge of the environmental and genomic factors underlying breast cancer risk throughout the lifespan. The Consortium will include:

Six to eight individual Windows of Susceptibility research projects employing transdisciplinary research aims to investigate the influence of environmental exposures during specific time windows on breast cancer risk (to be supported under a parallel FOA, RFA-ES-14-012 ), and

A single BCERP Coordinating Center (to be supported under this FOA).

Collectively, the BCERP Windows of Susceptibility projects and Coordinating Center will form a consortium of multi-disciplinary teams that will work collaboratively to conduct high-quality, transdisciplinary research focused on the impacts of environmental exposures during specific windows of susceptibility on breast cancer risk. The BCERP Consortium will also develop and implement strategies to translate and communicate these research findings to appropriate stakeholders.

The main role for the BCERP Coordinating Center will be the integration of efforts across the BCERP Consortium and facilitation of transdisciplinary research. The BCERP Coordinating Center will be expected to do this by communication, coordination, and collaboration across multiple participating research institutions of BCERP as well as close interactions with NIH program staff members.

The BCERP Coordinating Center will be responsible for the following strategic objectives for the BCERP Consortium:

Facilitate transdisciplinary research through scientific leadership and organizational support with emphasis on efficient communication, coordination of efforts, and scientific collaboration across multiple research projects spanning multiple research institutions.

Facilitate and mediate contacts between BCERP awardees and NIH program staff to allow for efficient interactions, consultations, and NIH’s oversight functions.

Create and manage relevant logistical infrastructure to support the BCERP consortium.

Create opportunities to disseminate results across multiple venues.

Transdisciplinary research is defined as research that involves scientists from multiple disciplines, as well as community partners, working interactively on a common problem to develop novel cross-disciplinary methods, insights, and research approaches that would not have occurred with a traditional single-disciplinary investigation. Each BCERP Windows of Susceptibility project will focus on a basic science model in coordination with human research and include community engagement activities (see "Research Objectives and Requirements for BCERP Research Projects" under Section I of RFA-ES-14-012 for additional details). The BCERP Coordinating Center is charged with facilitating the transdisciplinary goals and nature of the program on a consortium-wide level, both intellectually and administratively, in coordination with NIH staff.

Given the disparate impact of breast cancer on women and strong evidence that environmental exposures at specific stages of breast development can influence breast cancer risk, the BCERP program is specifically focused on female breast cancer. Applications that focus on male breast cancer will be considered non-responsive to this announcement and will not proceed to review. Investigators interested in submitting an application on male breast cancer are encouraged to contact Scientific/Research staff listed under "agency Contacts" in Section VII.

Background

Researchers have long accepted that breast cancer is a complex disease and that both genetic and environmental factors contribute and interact with each other to increase breast cancer risk. The identification of different environmental factors that influence breast cancer risk presents a tremendous opportunity to prevent breast cancer. The BCERP, a joint effort by the NIEHS and the NCI, began in 2003 (RFA-ES-03-001) and was renewed in 2010 (RFA-ES-09-008, RFA-ES-09-009, RFA-ES-09-010). The BCERP represents one of the first research initiatives to directly examine the influence of environmental exposures at likely windows of susceptibility, such as puberty, to evaluate how environmental exposures influence early events that may affect the risk for female breast cancer. A focus on earlier windows of susceptibility is important since lack of progress in identifying environmental determinants of breast cancer risk may be attributable, in part, to the focus of previous research on adult exposures after the relevant windows may have passed. In addition, the BCERP is a unique transdisciplinary program that strives to combine epidemiologic, basic and social sciences, as well as advocate communities, to better understand and advance breast cancer prevention. This approach is vital to stimulate new research approaches and accelerate the translation of research findings into disease prevention. As such, a major focus of the BCERP is to ensure that new findings are disseminated to girls and women at risk by engaging breast cancer advocates and other community groups in the appropriate translation of the research findings for their local communities. Additional details about the BCERP program, including previously funded research, publications and community engagement activities, can be found at http://bcerp.org/index.htm.

Concurrently, in response to the 2008 Breast Cancer and Environmental Research Act, the NIEHS and NCI established the Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERCC). The goals of the IBCERCC were to develop a report to outline the current state of research on breast cancer and the environment; identify key research questions, methodologies, and knowledge gaps; and make recommendations for accelerating the identification and mitigation of the environmental causes of breast cancer. A copy of the full IBCERCC report is available at http://www.niehs.nih.gov/about/boards/ibcercc/.

Research Objectives

This FOA aims to build upon emerging findings from the BCERP while also drawing upon the expert recommendations of the IBCERCC. The continuing goal of the BCERP is to support integrated scientific research to enhance our knowledge of environmental and genetic factors underlying breast cancer risk over the lifespan of a woman. This FOA will build upon current successes of the BCERP and explore additional research questions by:

Expanding investigations to include additional intermediate risk factors for breast cancer (such as high breast density and benign breast disease) to increase our understanding of how these factors are impacted by environmental exposures at specific life stages.

Expanding investigations to additional windows of susceptibility (such as post-puberty adolescence, time at first birth and menopause) and explore additional exposures and mechanisms within windows already under investigation.

Providing opportunities to test new transdisciplinary research hypotheses to advance research and facilitate preventive strategies.

One prominent goal is to place greater emphasis on leveraging and building upon existing knowledge, community partner interests, and the creation of transdisciplinary teams in generating research hypotheses and study designs for individual research projects. In addition, an emphasis will be placed on promoting coordination between the BCERP Consortium and the broader breast cancer and environmental health science research communities.

Structure of the BCERP Consortium

The BCERP Consortium will include a group of 6-8 transdisciplinary research projects with community-academic partnerships and a Coordinating Center to integrate efforts across the individual projects. All BCERP projects will work collaboratively with the BCERP Coordinating Center and NIH staff to establish a common Vision and Mission Statement for the Consortium as well as identify shared resources that can support needs across projects and maximize the collaborative nature and impact of the program. Members of the BCERP Consortium will be required to participate in Consortium networking/collaborative activities, including a yearly face-to-face meeting for the exchange of information across research projects as well as to the broader public. In addition, BCERP members will participate, as appropriate, in "working group" subcommittees formed around topics that cross-cut the BCERP Consortium (such as specific windows of susceptibility, specific exposures, and/or community engagement). The Coordinating Center, in conjunction with NIH staff, will facilitate collaborations among the research projects and community partners as well as provide logistical support for all Consortium interactions. The BCERP Consortium will be governed by a Steering Committee comprised of representatives from the funded research projects (including academic and community partners), the Coordinating Center and NIH program staff. (See section, below, on Program Governance).

What are the underlying mechanisms linking environmental exposure at different life stages with alterations in the mammary gland?

How do genetics, social determinants of health, or lifestyle factors modify the impact of environmental exposures and contribute to the overall risk of breast cancer?

What strategies for prevention are indicated by the connections between exposure, intermediate risk factors, and underlying mechanisms?

How can findings be best translated into effective risk messages for various communities or to inform policy?

Requirements for BCERP Coordinating Center

The BCERP Coordinating Center will have the critical role of integrating efforts of the individual BCERP Windows of Susceptibility research projects funded under a companion FOA (RFA-ES-14-012 ). This leading role will require the BCERP Coordinating Center applicant team to possess prior experience in coordinating large multi-site programs, providing logistic infrastructure for such programs, organizing evaluation criteria for the program, and disseminating results.

The BCERP Coordinating Center will provide intellectual and scientific leadership as well as logistic support infrastructure for the overall BCERP consortium. A primary role of the BCERP Coordinating Center will be to identify commonalities in research questions being explored across sites and opportunities to facilitate collaborations, oversee pilot projects, assist in exploring novel hypotheses, and, thus, extend the transdisciplinary activities of the program. The BCERP Coordinating Center will:

Identify research activities across projects that could be integrated or standardized to minimize duplication and maximize the use of resources.

Identify scientific problems that could be jointly explored and coordinate development of collaborative projects.

Oversee an “Opportunity Fund” pilot project program to help support new transdisciplinary research questions that emerge from the program.

Establish and coordinate topical “Expert Working Groups” around key scientific issues that cross-cut individual projects, and help identify other investigators working in relevant research fields but not directly funded by BCERP to join these working groups (such as NIH intramural investigators, extramural investigators supported by other NIH programs, and federal partners).

Provide logistical support for Consortium activities by providing state of the art cross-project communication, a project web site, and working with program staff and Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to organize the biannual meetings.

Assist NIH Staff in regularly evaluating the program to assess whether transdisciplinary goals are being met.

Serve as a research data management center as appropriate.

Facilitate development and assist in dissemination of study findings to relevant stakeholders in coordination with Windows of Susceptibility investigators and community partners.

Organize annual meetings and regular conference calls for the Steering Committee and its subcommittees, BCERP-supported investigators and community partners, and the public.

It is anticipated that BCERP Coordinating Center personnel will have expertise and strong prior experience in biostatistics, evaluation and team science, and a record of excellence in coordinating large multi-site programs, providing logistic infrastructure, and organizing related dissemination programs.

Required Structure and Main Responsibilities of the BCERP Coordinating Center:

The BCERP Coordinating Center will be responsible for the following main aspects of the BCERP Consortium:

I. Leadership and Logistical Support.

The BCERP Coordinating Center will be led by an experienced Director (PD/PI) and must be able to provide close coordination of transdisciplinary research efforts of the BCERP Consortium. This role will require strong experience in leading team science initiatives to promote cross-disciplinary collaboration and provide scientific guidance on how to maximize the overall transdisciplinary nature of the program. Although not required, experience in environmental health and/or breast cancer research among the proposed research team is desirable. Responsibilities of the BCERP Coordinating Center will include, but are not limited to,

providing overall leadership in "team science" for the BCERP Consortium;

compiling state-of-the-art methods and models in use across the BCERP Consortium and facilitating the leveraging of their use across projects;

establishing topical “Working Groups” relevant to research and scientific needs across the initiative; and

The BCERP Coordinating Center will be responsible for coordinating collaborative research to be developed and conducted by BCERP awardees post-award. Responsibilities of the BCERP Coordinating Center will include, but are not limited to,

identifying commonalities in research directions and specific questions being explored across the BCERP Consortium to promote cross-BCERP collaborative efforts; and

coordinating and/or facilitating th development of new collaborative projects. To enable developmental cross-BCERP projects, the BCERP Coordinating Center will oversee a pilot project fund, referred to as the “BCERP Opportunity Funds”. The Coordinating Center will be responsible for developing a plan for how potential projects will be identified, selected, and managed. These Opportunity Funds will be restricted and their use for specific projects must be approved by the NIH.

III. Resource and Data Sharing, and Bioinformatics.

The BCERP Coordinating Center will facilitate data sharing and results dissemination across BCERP awardees and between the BCERP and the NIH. It is expected that this aspect will involve resources and personnel at individual BCERP project sites. Responsibilities of the BCERP Coordinating Center will include, but are not limited to,:

facilitating the development of publication, biospecimen, and data use policies in coordination with the BCERP Steering Committee and NIH program staff;

establishing and maintaining secure websites for the public and for internal BCERP uses;

facilitating access to individuals with specialized expertise in biostatics and bioinformatics, as needed to support cross-BCERP projects; and providing data management functions for the Consortium, as appropriate.

IV. Education and Outreach.

The BCERP Coordinating Center will facilitate the broader dissemination of research findings to relevant stakeholders and promote forums to share outcomes of the BCERP Consortium. Responsibilities of the BCERP Coordinating Center will include, but are not limited to,

facilitating the integration of findings across the consortium and promoting BCERP research;

organizing sessions, in coordination with BCERP Windows of Susceptibility Investigators and NIH staff, to present BCERP outcomes at relevant national and international scientific meetings; and

These elements must be coordinated with community partners, BCERP Consortium investigators, and NIH program staff.

V. Integration and Internal Evaluation.

The BCERP Coordinating Center will enable timely internal evaluation of the BCERP Consortium to identify and promote effective self-correcting actions. In this area, the BCERP Coordinating Center will have to closely collaborate with the BCERP Steering Committee, individual BCERP investigators, and NIH Program Staff. This internal evaluation system should track the relative contribution of each individual Windows of Susceptibility research project to the overall goals of the BCERP Consortium and provide feedback need to optimize the transdisciplinary nature of the consortium.

Areas of the internal evaluation and desirable outcomes should include, but are not limited to,

In addition to the internal evaluation, the entire BCERP Consortium will be subject to external evaluation to be coordinated by the NIH Program Staff. The internal evaluation of the BCERP Consortium will be essential for facilitating and enhancing the external program evaluation. The BCERP Coordinating Center will be expected to cooperate with the NIH in the external evaluation process. See External Evaluation of BCERP below.

BCERP Consortium Governance

The BCERP Steering Committee will serve as the governing board for the BCERP. The Steering Committee will serve as a forum for the Windows of Susceptibility research projects and the Coordinating Center to share findings and progress across the Consortium on an ongoing basis, determine the need for redirection in scientific focus in order to accommodate new knowledge, and recommend new opportunities and directions for the BCERP. The Steering Committee will be the guiding entity for the BCERP. In the event that individual project site PD(s)/PI(s) cannot reach agreement on critical aspects of the project, such as common protocols, then the Steering Committee, in consultation with NIH Project Staff, will make a final decision on how to proceed. Though the Steering Committee will make recommendations, NIEHS and NCI Staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and Federal Guidelines.

Additional details on the composition and functions of BCERP Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award, “Collaborative Responsibilities.”

External Evaluation of BCERP

At the option of NIH Staff, BCERP awardees may be expected to participate in an external evaluation process. The purpose of the evaluation would be to monitor and assess the performance of the BCERP awardees in achieving the goals of the BCERP. This activity includes evaluating the quality and innovation of the research conducted in the BCERP Consortium, including the Coordinating Center, as well as assessing critical intermediate determinants of the overall success, such as infrastructure development and capacity building, linkages and resource sharing arrangements within and among the BCERP Consortium, and the transdisciplinary nature of the research. Outcomes to be assessed will include quantity and quality of peer-reviewed publications, success of educational and outreach programs, and effectiveness of the transdisciplinary research model. All funded projects are required to maintain searchable records and to be prepared to share additional requested information with NIH when requested.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIEHS and NCI intend to commit $1.0 million per year for 5 years. It is anticipated that one award will be made through this announcement.

Award Budget

Application budgets are limited to no more than $600,000 Direct Costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

Biosketch: The applicant should demonstrate experience and expertise of the PD(s)/PI(s) in team science and conducting coordinating functions for multi-site projects.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The Coordinating Center PDs/PIs and other key staff are required to participate in the annual in person BCERP meeting. Applicants should include funds to cover such travel in the requested budget.

To enable developmental cross-BCERP projects, BCERP Coordinating Center applicants must budget appropriate pilot project funds as “BCERP Opportunity Funds”. A recommended minimum of $100,000 direct cost per year (or $500,000 direct cost over the entire project period) should be requested in the budget with a clear plan for how potential projects will be identified, selected, and managed. Eligible uses for Opportunity Funds include, but are not limited to, supporting projects to evaluate common measures, or develop new methodologies that can be validated throughout the BCERP Consortium and potentially in larger populations. However, Opportunity Funds should not be used for duplicative activities that have already been supported under the awards for individual Windows of Susceptibility research projects within the BCERP Consortium.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

In lieu of the instructions for the Research Strategy in the SF 424 R&R Application Guide, the following items should be addressed satisfactorily by the applicant:

Overview of the Proposed Coordinating Center

The applicant should describe:

Overall vision for the BCERP Coordinating Center;

Major strengths and critical experience of the team;

Capability to promote and facilitate collaboration across multi-site studies and among investigators to identify common measures or constructs and standardize procedures for data collection and analysis;

Capability to design an internal evaluation framework for the Consortium, track relevant metrics, and disseminate results

Innovative value and potential of the proposed Coordinating Center functioning for facilitating transdisciplinary research in breast cancer and the environment.

Leadership and Logistics

The organization of the BCERP Coordinating Center leadership team and propose infrastructure to support the required administrative activities of the BCERP Consortium. The application should include plans to:

Provide organizational and scientific leadership to facilitate interactions among the BCERP Consortium and NIH.

Compile state-of-the-art methods for data collection, novel biomarkers, laboratory procedures and models in use across the BCERP Consortium, and leverage their use.

Bring together expertise from across the BCERP Consortium and establish topical “Working Groups” (such as groups focused on specific windows of susceptibility, specific exposures, or community engagement) relevant to the funded BCERP research and scientific needs across the initiative.

Provide logistical support for all the activities of the Steering Committee and its subcommittees.

Organize annual meetings and regular conference calls for the Steering Committee and its subcommittees, BCERP-supported investigators and community partners, and the public.

Enable state-of-the-art cross-site communication for BCERP awardees.

Developmental Cross-BCERP Coordination

The applicant should describe:

Proposed approach to identify commonalities in research directions and specific questions being explored across BCERP Windows of Susceptibility projects

Methods to facilitate and promote standardization of research approaches and sharing of resources across BCERP projects working on common issues.

Plans for managing the BCERP pilot “Opportunity Fund”, including the schedule for soliciting pilot project proposals and how potential pilot projects will be identified, selected, and managed.

Resource and Data Sharing and Bioinformatics

The applicant should describe:

Capabilities to support proposed trans-BCERP projects and data sharing among the BCERP Consortium, for example, through the establishment and maintenance of a secure internal BCERP Consortium web portal, access to existing data storage and management infrastructure, etc.;

Capabilities to facilitate the development of publication, biospecimen, and data use policies. Note that the data management functions of the BCERP Coordinating Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site. However, the BCERP Coordinating Center may also serve as a clearing house for data storage and management to the extent that common data elements will be collected across multiple research projects and it is determined that centralization of such data would be beneficial to the BCERP Consortium by the BCERP Steering Committee (see section below on BCERP Consortium Governance below).

Other innovative methods by which the BCERP Coordinating Center will stimulate communication and resource and information sharing across the BCERP Consortium members.

Education and Outreach

The applicant should describe:

Capabilities to support the establishment and maintenance of an external BCERP Consortium website.

Proposed methods to facilitate communication between the BCERP Coordinating Center and investigators/community partners in the overall BCERP Consortium as well as investigators involved in complementary research outside of BCERP.

Outreach activities and relevant methods to disseminate information about BCERP and its results to breast cancer and environment research and advocacy communities, including workshops, external seminar series, sessions at scientific meetings, etc.

Integration and Internal Evaluation

The applicant should describe:

Capabilities to collaborate with the BCERP Consortium and NIH program staff;

Capabilities to establish an evaluation system for the Consortium, including establishment of searchable records that can be later leveraged for the BCERP external evaluation;

Methods for evaluating the contribution of each BCERP Windows of Susceptibility project the overall Vision and Mission of the BCERP Consortium; and

Methods for evaluating the overall performance and transdisciplinary nature of BCERP Consortium.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, are expected to provide a Data Sharing Plan, consistent with achieving the goals of the program.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How well will the proposed Coordinating Center serve the goals of the BCERP Consortium?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the PDs/PIs and BCERP Coordinating Center investigators and key personnel well-qualified for participating and managing multi-site collaborations and facilitating and coordinating interactions and communication among investigators and staff from multiple institutions? Are the backgrounds, expertise, and commitments of the PDs/PIs and other key personnel sufficient for the proposed scope of activities and in line with the overall goals for the BCERP Coordinating Center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are new approaches proposed that would streamline research processes, improve communication, collaboration, creativity and performance within the BCERP Consortium?

Does the plan for resource and data sharing and bioinformatics describe a program that will efficiently support the sharing of data and information resources across the BCERP Consortium?

Are the proposed educational and outreach activities appropriate and adequate to support the BCERP goals? Is the proposed plan to synthesize and disseminate BCERP research results adequate to provide meaningful information to both researchers and community stakeholders?

Does the evaluation plan demonstrate a capacity for the BCERP Coordinating Center to collaborate within the BCERP Consortium and NIH program staff on critical evaluation of the

transdisciplinary nature of the program and dissemination of research findings?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Environmental Health Sciences, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of BCERP research in accordance with terms and conditions of the award.

All PD(s)/PI(s) of the BCERP Consortium (Coordinating Center and Windows of Susceptibility research projects) will have the primary responsibility for:

Overseeing the budget and activities of the award, as detailed, above.

Cooperating with other BCERP investigators and community partners and NIH Staff, as appropriate, in the design and conduct of protocols, analysis of data, and reporting of results of research undertaken by the BCERP. This includes, but is not limited to:

Providing goals and estimated costs for procedures and protocols.

Sharing data, protocols and other research resources generated through the BCERP award.

Promoting and coordinating cross-BCERP scientific collaboration.

Ensuring training of study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry.

Facilitating the formation of and participating in appropriate Working Groups to promote the exchange of preliminary findings, experiences, protocols, and ideas across the BCERP.

Interacting and complying with requests for information from the BCERP Steering Committee and other sub-committees as appropriate.

Participating in the annual PD/PI scientific meetings, and monthly committee calls organized by the BCERP Coordination Center, as relevant.

Cooperating in the program evaluation activities.

Accepting and implementing all scientific, practical, and policy decisions approved by the BCERP Steering Committee to the extent consistent with applicable grant regulations.

Providing information to the NIH Program Directors and Project Scientists concerning progress by submitting annual progress reports in a standard format.

Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

The PD/PI responsible for the BCERP Coordinating Center will have the following additional responsibilities:

Organizing the development of BCERP Steering Committee and other BCERP sub-committees.

Organizing and providing logistical support for Steering Committee, Working Groups and other sub-committees.

Budgeting for, organizing, and providing logistical support for the annual BCERP Scientific Meeting.

Identifying, collecting and managing relevant protocols, data and other resources used by the BCERP Consortium members.

Overseeing an “Opportunity Fund” pilot project program, with significant input from NIH Program Staff and the BCERP Steering Committee, to support new transdisciplinary research questions that emerge from the program.

Serving as the executive secretary for the Steering Committee, which at a minimum includes compiling monthly minutes and quarterly summaries of consortium-wide activities.

Coordinating cross-BCERP training for Windows of Susceptibility research projects' personnel as needed for standardization of collaborative protocols across sites, etc.

The BCERP Consortium will be subject to periodic internal evaluation (coordinated by the BCERP Coordinating Center) and external evaluation (coordinated by the NIH). All BCERP Consortium Awardees will be expected to participate in such evaluations.

All BCERP Consortium awardee institutions/organizations will be expected to share with other BCERP awardees knowledge, data, research materials, and any other resources necessary and relevant to the BCERP Consortium.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One or more NIEHS and NCI Program Directors will be substantially involved in the BCERP Consortium as NIH Project Scientists. NIH Project Scientists will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.

NIEHS and NCI Project Scientist(s) will have the following responsibilities to all BCERP Consortium awardees:

Have substantial involvement to guide, coordinate, and participate in the conduct of the BCERP Consortium activities.

Attend and participate in all Steering Committee and subcommittee meetings of the BCERP Consortium.

Coordinate and facilitate the interactions among the awardees under this U01 cooperative agreement.

Serve as a liaison between the Steering Committee, the BCERP Consortium, the NIH and other federal agencies as needed.

Monitor the operations of the BCERP Coordinating Center and Windows of Susceptibility projects, review their progress and compliance with the operating policies of the Steering Committee, and make recommendations on overall project directions and allocations of project funds.

Facilitate and coordinate the exchange of information and interactions between Consortium awardees to support collaborative efforts.

Along with the Coordinating Center, participate in organizing and coordinating annual BCERP Scientific meeting.

Advise on the design of research activities, availability of resources, and/or management and technical performance of projects, as appropriate.

Participate as collaborators to the BCERP investigators in some shared activities, if appropriate.

Assist in avoiding unwarranted duplications of effort across the BCERP Consortium.

Participate in the BCERP Consortium evaluation activities, including coordination of an external evaluation of the BCERP Program.

Evaluate the adherence of BCERP awardees to any approved data sharing plans or intellectual property plans.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those BCERP awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

Areas of Joint Responsibility include:

A Steering Committee will serve as the governing board for the BCERP Consortium.

The BCERP Steering Committee will have primary responsibility for:

Overseeing the overall organization of the BCERP initiative and for reviewing its research goals.

Monitoring transdisciplinary progress of the Consortium.

Developing the appropriate structure of Working Groups to promote the exchange of experiences, protocols, novel research findings, etc. across the BCERP.

Establishing advisory committees and subcommittees, as necessary, to serve the BCERP Steering Committee and the BCERP awardees.

Reviewing the potential for sharing resources located at individual Windows of Susceptibility project sites to serve the needs of other BCERP projects or the entire initiative.

Making recommendations for re-directing the Consortium's focus in order to accommodate new scientific opportunities and directions and maximize the transdisciplinary nature of the BCERP Consortium.

Sharing and reviewing annual progress among the projects of the BCERP.

The Steering Committee will be comprised of the following voting members:

The PD(s)/PI(s) of the BCERP Coordinating Center (RFA-14-011), who will have one vote.

A research investigator or community partner representative of each individual BCERP Windows of Susceptibility research projects (RFA-14-012), who will have one vote.

One NIEHS and one NCI project scientist, who will each have one vote, so long as the total NIH votes do not exceed 1/3 of the committee membership.

Other NIH staff members may participate in Steering Committee meetings as non-voting members.

The PD(s)/PI(s) and lead Community Partner for each Windows of Susceptibility award will agree to serve at least one 2-year term within the project period. Only one representative from each project will serve on the Steering Committee at a given time.

Steering Committee representatives from each project will be elected at the initial BCERP Consortium meeting and should reflect a balance between research investigators and community partners.

A Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.

In the event that PD(s)/PI(s) cannot agree on critical aspects of the Consortium, such as common protocols, then the Steering Committee, in consultation with NIH Program Staff, will vote on a recommendation for how to proceed. NIEHS and NCI Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.

Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.

The BCERP Steering Committee may establish an External Advisory Board, comprised of scientific experts from outside the BCERP initiative, to serve the NIH staff, the BCERP Steering Committee and the BCERP awardees.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel comprised of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.